Pressure based spontaneous inflation inhibitor with penile pump improvements

ABSTRACT

A pump assembly for a penile implant is provided having a mechanism which prevents spontaneous inflation of the cylinders implanted within the patient. The pump assembly has an actuating bar with ribs to enhance the spring force applied to a flow valve, a support structure to support and appropriately position the actuating bar, and a check valve made of metal with a segment covered with a plastic material. The preventative mechanism uses overpressure generated by the reservoir during unintentional compression to effectively seal the cylinders from unintended fluid flow. The prevention mechanism itself creates all necessary forces to prevent the undesired fluid flow to the cylinders. This is accomplished by incorporating appropriate mechanisms within the pump itself.

REFERENCE To RELATED APPLICATIONS

[0001] This application is a continuation-in-part of U.S. patentapplication Ser. No. 09/749,292 entitled “PRESSURE BASED SPONTANEOUSINFLATION INHIBITOR” which was filed Dec. 27, 2000, and claims thepriority of provisional application Serial No. 60/295,326 entitled“PENILE PUMP IMPROVEMENTS” which was filed Jun. 1, 2001 (the entirecontents of each of which are herein incorporated by reference).

BACKGROUND

[0002] This invention generally relates to a pump and valve assembly forinflating a prosthesis. More particularly, the invention relates topressure based mechanisms that inhibit spontaneous inflation of theprosthesis, including stiffening and support mechanisms that alsoimprove the function of the valve.

[0003] One common treatment for male erectile dysfunction is theimplantation of a penile prosthesis. Such a prosthesis typicallyincludes a pair of inflatable cylinders which are fluidly connected to afluid (typically liquid) reservoir via a pump and valve assembly. Thetwo cylinders are normally implanted into the corpus cavernosae of thepatient and the reservoir is typically implanted in the patient'sabdomen. The pump assembly is implanted in the scrotum. During use, thepatient actuates the pump and fluid is transferred from the reservoirthrough the pump and into the cylinders. This results in the inflationof the cylinders and thereby produces the desired penis rigidity for anormal erection. Then, when the patient desires to deflate thecylinders, a valve assembly within the pump is actuated in a manner suchthat the fluid in the cylinders is released back into the reservoir.This deflation then returns the penis to a flaccid state.

[0004] With inflatable penile prostheses of current designs, spontaneousinflation of the cylinders is known to occasionally occur due toinadvertent compression of the reservoir, resulting in the undesiredintroduction of fluid into the cylinders. Such inadvertent inflation canbe uncomfortable and embarrassing for the patient. This undesirablecondition is further described below with reference to a particularprosthetic design.

[0005] With reference to FIG. 1, a known pump and valve assembly 8 foruse in a penile prosthesis includes a fluid input 10 that is coupled atone end to a reservoir (not shown) and to a housing 12 at its oppositeend. Also connected to the housing 12 is a fluid output 14 which, inturn, is connected at its other end to a pair of cylinders (not shown).Linking the fluid input 10 and the fluid output 14 to each other is acommon passageway 33, which itself contains a valve assembly that isdescribed in greater detail below. Common passageway 33 is also in fluidcommunication with a pump bulb 18 that is used to move fluid from thereservoir (not shown) to the cylinders (not shown) in order to inflatethe cylinders. The valve assembly located within common passageway 33includes a reservoir poppet 20 which is biased against a valve seat 24by a spring 28 and a cylinder poppet 22 which is biased against a valveseat 26 by a spring 30. The springs 28 and 30 are sized so as to keepthe reservoir poppet 20 and the cylinder poppet 22 biased against eachrespective valve seat 24 and 26 under the loads that are encounteredwhen the reservoir is pressurized to typical abdominal pressures.

[0006] When the patient wishes to inflate the cylinders, pump bulb 18 issqueezed so as to force fluid from the pump bulb 18 into the commonpassageway 33. The resulting fluid flow serves to reinforce the forcefrom the spring 28 urging the reservoir poppet 20 against valve seat 24while at the same time causing compression of the spring 30, and therebyopening cylinder poppet 22. As a result, the fluid travels out throughfluid output 14 and into the respective cylinders.

[0007] When the patient releases the pump bulb 18 a vacuum is created,thus pulling the poppet 22 back against valve seat 26 (aided by spring30) and simultaneously pulling the reservoir poppet 20 away from itsvalve seat 24, against the spring 28. As a result, fluid from thereservoir is thus allowed to flow through the fluid input 10 and intothe common passageway 33 passing around the reservoir poppet 20 and intothe vacuous pump bulb 18. Once the pump bulb 18 has been filled, thenegative pressure is eliminated and the reservoir poppet 20 returns toits normal position. This pumping action of the pump bulb 18 and valveassembly is repeated until the cylinders are fully inflated.

[0008] To deflate the cylinders, the patient grips the housing 12 andcompresses it along the axis of reservoir poppet 20 and cylinder poppet22 in a manner such that the wall 13 of the housing 12 contacts theprotruding end 21 of the reservoir poppet 20 and forces the reservoirpoppet 20 away from valve seat 24. This movement, in turn, causes thereservoir poppet 20 to contact cylinder poppet 22 and force cylinderpoppet 22 away from valve seat 26. As a result, both poppets 20 and 22are moved away from their valve seats 24 and 26 and fluid moves out ofthe cylinders, through the fluid output 14, through common passageway33, through the fluid input 10 and back into the reservoir.

[0009] Although the springs 28 and 30 are sized to provide sufficienttension to keep poppets 20 and 22 firmly abutted against valve seats 24and 26 under normal reservoir pressures, it is possible that pressurethat exceeds the force provided by the springs could be exerted upon thereservoir during heightened physical activity or movement by thepatient. Such excessive pressure on the reservoir may overcome theresistance of the spring-biased poppets 20 and 22 and thereby cause aspontaneous inflation of the cylinders. After implantation,encapsulation or calcification of the reservoir may occur. Encapsulationor calcification of the reservoir can lead to additional problems. Inparticular, the encapsulation could lead to a more snugly enclosedreservoir, thus increasing the likelihood of spontaneous inflation.

[0010] In previous attempts to reduce or eliminate the occurrence ofspontaneous inflation, different types of spontaneous inflationpreventing valves have been introduced into the pump and valve assembly.Such previous valves are intended to permit the positive flow of fluidto the cylinders only in those circumstances when the patient hasforcibly manipulated the valve.

[0011] Although such previous valve designs reduce the frequency ofspontaneous inflation, several drawbacks do exist. For example, suchvalves are typically complex, requiring two-handed operation which is aserious drawback to elderly or severely ill patients. Some spontaneousinflation preventing valves also require the application of excessiveforce in order to manipulate the valves; which may be too demanding forsome patients. Furthermore, such valve designs may cause patientdiscomfort due to the valve size or shape, because of increase in theoverall volume of the implant within the patient. This increased sizecan also lead to interference with the patient's normal bodilyfunctions. Such previous valve designs typically add undesirable cost tothe device as well as increase the complexity of the surgicalimplantation procedure.

[0012] A solution to the above-identified drawbacks is disclosed inco-pending U.S. patent application Ser. No. 09/749,292 entitled“PRESSURE BASED SPONTANEOUS INFLATION INHIBITOR” which is assigned tothe Assignee of the present invention and is incorporated herein byreference. However, the operational efficiency of the prosthesis pumpcould be further improved by optimizing the operative manipulation ofthe assembly.

[0013] Presently, the pump and valve assemblies used in implantableprostheses share certain characteristics. A compressible pump bulb isattached to the housing and is in fluid communication with the variousfluid pathways. In order to inflate the cylinders, the compressible pumpbulb is actuated by the patient, thereby urging fluid past the poppetsinto the cylinders. In order to deflate the cylinders, the valve housingis grasped and squeezed (through the patient's tissue), causing thepoppets to unseat and allow fluid to flow back to the reservoir.

[0014] Since the pump and valve assembly is positioned within thepatient's scrotum, the various components of the assembly must be small.As a result, manipulation of the pump and valve assembly is sometimesdifficult. For example, patients requiring the use of a penileprosthesis are oftentimes elderly and have a reduced dexterity as aresult of aging. Thus, in some instances, even locating the devicewithin the tissue can be a challenge, let alone identifying the correctportion of the assembly to actuate. More specifically, with somepatients it may be difficult to determine whether the housing portion ofthe assembly that leads to release or deflation of the cylinders isbeing grasped, or whether the bulb portion which would be used toinflate the cylinders is being grasped.

[0015] Notably, the length of the valve assembly is determined (at leastin one direction) by the size of the various poppets and the distancesuch poppets must move in order to open and close the various fluidpassageways. As a result, such a pump and valve assembly typically islonger in a direction parallel with the poppets. Moreover, in order torelease the poppets in an assembly configured in this manner, thepatient must grasp the narrower, shorter sidewalls of the assembly andcompresses them together. Such a configuration can present challengesinsofar as the spring tension of the poppets at the time of desireddeflation is typically at a maximum while the surface area of theassembly which must be compressed in order to cause such deflation is ata minimum. This condition can lead to a situation where the patient hasdifficulty actually compressing the assembly, or in extremecircumstances, actually loses grip of the assembly during such attemptsat deflation.

[0016] There exists a need for an improved prosthetic penile implanthaving a spontaneous inflation prevention mechanism that affordsconvenient operative manipulation by a patient.

SUMMARY OF THE INVENTION

[0017] The present invention includes a penile pump having a dual poppetarrangement wherein the poppets act as check valves or flow valves. Eachpoppet is spring-biased against a valve seat, and under normalcircumstances, only allows positive fluid flow when a pump bulb isoperated, thus causing an increase in fluid pressure which istransferred to the inflatable cylinders. To prevent spontaneousinflation when an overpressurization occurs in the reservoir, the samereservoir pressure is utilized to seal the fluid output against itselfor to seal one or both of the poppets against the valve seat. Thus, thefluid is prevented from reaching the cylinders and creating aspontaneous inflation. When the movement or activity generating theoverpressure in the reservoir is released, the system should return toequilibrium. Even if overpressurization of the reservoir is occurring,the pressure generated by compressing the pump bulb will far exceed thelevel of overpressure. Thus, the poppets will open in the normal way,allowing fluid to flow to the cylinders. The use of the overpressure inthe reservoir itself to prevent fluid flow to the cylinders can occur ina variety of formats.

[0018] In still another embodiment, the reservoir poppet is actuallycoupled to an outer wall defining a portion of the fluid input. When anoverpressurization in the reservoir occurs, this outer wall is forced toexpand which simultaneously causes the reservoir poppet to be pulledfirmly against the valve seat. This effectively prevents fluid flow fromreaching the cylinders and causing a spontaneous inflation.

[0019] In yet another embodiment of the present invention, the valveseat is provided with a flexible valve which cooperates with the firstpoppet to prevent spontaneous inflation which could be caused byexcessive pressure in the reservoir. Specifically, pressure in thereservoir and associated valve input is presented to the flexible valveand thus causing the valve to be further forced against the poppet, thussealing off the input. When inflation is desired however, the negativepressure pulling the first poppet away from the valve seat will allowthe desired fluid flow.

[0020] In yet still another embodiment, a tapered poppet is utilized inconjunction with a tapered valve seat. Each of these tapers do notexactly match each other, thus providing variable reactions to pressuresignals.

[0021] In a further embodiment, a section of the reservoir poppetprotrudes into the reservoir chamber. This protruding section of thereservoir poppet is coupled to the outer wall of the reservoir chamber.The poppet is coupled to the wall with a connecting spring that permitsrelative movement between the poppet and the outer wall. The tension ofthe spring is selected so that it approximates the forces generated bypressurized fluid acting on the wall of the reservoir chamber. However,the spring force is not so great as to prevent the vacuum generated bythe pump bulb from opening the poppet. Thus, when the pump bulb iscompressed and released, the vacuum forces generated are sufficient tounseat to the reservoir poppet despite its connection to the outerreservoir chamber wall.

[0022] In yet still a further embodiment, a relatively large andpowerful biasing spring is coupled with the reservoir poppet to exert arelatively large force against the reservoir poppet forcing it into asealing or closed position. Due to the strong biasing forces of thespring, overpressurization forces generated in the reservoir chamber areinsufficient to unseat the reservoir poppet. Simply using such a springwill make it difficult for the vacuum forces generated by compression ofthe pump bulb to unseat the reservoir poppet. To eliminate this problem,the face of the reservoir poppet, which forms a fluid-tight seal whenthe reservoir poppet is in a closed position, is made relatively large.That is, the diameter of the face approaches the diameter of the chambercontaining the reservoir poppet. Thus, the vacuum forces generated willact over a larger surface area thereby exerting a larger degree offorce, which permits the unseating of the reservoir poppet despite theopposing force of the biasing spring.

[0023] Because it is difficult to fabricate a housing having a planarwall that interacts with the planar poppet face to form a sufficientlyfluid-tight seal, the portion of the housing holding the reservoirpoppet contains a pair of spaced lip seals. The position of the lip sealserves two distinct purposes. The first is to prevent fluid pressuregenerated during over pressurization of the reservoir from engaging alarge portion of the poppet face, which would in effect defeat the addedstrength provided by the biasing spring. The outer seal is also providedso that when a vacuum force is generated, the vacuum cannot act on thefront surface of the poppet face which would, in effect, hold thereservoir poppet in a closed position.

[0024] In another embodiment of the present invention, the reservoirpoppet is configured with a throughbore at a rear portion of thereservoir poppet that is in fluid communication with a passageway and anoutlet adjacent to the cylinder poppet. A sliding valve seal ispositioned over this section of the reservoir poppet. The sliding valveseal is held against the back wall of the chamber by a spring positionedbetween the front face of the sliding valve seal and the back face ofthe suction poppet valve seal. The arrangement of the valve sleeve onthe rear of the reservoir poppet is such that fluid is only able to flowthrough the throughbore and out of the outlet when the valve sleeve ispositioned near the rear of the chamber and the front face of thereservoir poppet is firmly seated. In a reservoir overpressurizationsituation, the valve sleeve is again pressed against the rear of thechamber. However, the reservoir poppet is also forced backwards into thechamber, forcing the throughbore to be occluded by the valve sleeve.This prevents fluid from flowing towards the cylinder poppet which couldultimately lead to spontaneous inflation.

[0025] In yet another embodiment, the portion of the housing between thecylinder poppet and the reservoir chamber has been modified. Inaddition, the reservoir poppet is provided with a unique configurationto interact with the housing structure. The reservoir poppet has a face,similar to the other embodiments, that is spring biased towards amatching valve seat. An annular ring is molded into the housing justbehind (towards the cylinder poppet) the valve seat and is sized tointeract with the face.

[0026] The pump assembly of this embodiment has two states, activatedand deactivated. In the activated state, the reservoir poppet ispositioned so that the face is between the annular ring and the valveseat. When so positioned, the pump assembly functions as previouslydescribed with reference to the other embodiments. A compression of thepump bulb force the face against the valve seat and causes the cylinderpoppet to open. A release of the pump bulb generates a vacuum whichremoves the reservoir poppet face from the valve seat and allows fluidto flow from the reservoir and into the pump bulb. Thus, the activatedstate is used when actively inflating the cylinders and while it isdesired to maintain the cylinders in an inflated state.

[0027] In the deactivated state, the reservoir poppet is positioned sothat the face moves through the annular ring. In this position, the facewill be between the cylinder poppet and the annular ring and thereservoir poppet spring will bias the face so that it abuts the annularring. In other words, the face is displaced from the valve seat, and agap exists between the valve seat and the annular ring. The stem of thereservoir poppet extends from the face towards the cylinder poppet. Thestem is a cylindrical member having a generally V-shaped grooveextending about its circumference near the middle of the stem. The steminteracts with a flexible conical lip seal molded within the housing.When in the activated state, the conical lip seal is positioned near theV-shaped groove so that fluid flow is essentially unhindered. When inthe deactivated state, the conical lip seal is caused to engage thecylindrical portion of the stem. Thus, a fluid tight seal can be formed.

[0028] When in the deactivated state, the reservoir poppet can be movedto engage and release the cylinder poppet, leading to a deflation of thecylinders. During this time, the conical lip seal continues to belocated near the cylindrical portion of the stem; however, the flexiblenature of the conical lip seal allows fluid flow in a direction from thecylinders to the reservoir. The pump assembly must be placed in thedeactivated state to prevent spontaneous inflation. When in this state,the conical lip seal engages the cylindrical portion of the stem. Ifoverpressure is generated, the reservoir poppet can be displaced towardsthe cylinder poppet. As this occurs, the increased fluid pressure levelsforce the conical lip seal to firmly abut the cylindrical portion of thestem, preventing increased pressure levels from reaching and displacingthe cylinder poppet. Thus, spontaneous inflation is prevented.

[0029] To further improve the operational efficiency of the pump andvalve assembly, in yet still another embodiment, a reservoir poppet ismade of a metal material with a plastic member disposed over a segmentof the metal material. The plastic segment of the reservoir poppetprevents undesired frictional contact (metal on metal) with other metalmembers, and prevents premature wearing of the contact point of the twocomponents.

[0030] In another embodiment, a pump and valve assembly includes a pumpbulb that is differentiated from the valve housing when inflation of thecylinders is desired. To supplement differentiation between the bulb andthe valve housing, the valve housing is provided with a textured surfaceso that even through tissue the patient is able to readily discern whicharea comprises the pump bulb and which area comprises the valve housing.This is important in that the pump bulb is compressed for inflationwhile the valve housing is compressed for deflation.

[0031] The pump assembly is configured such that it has a length longerthan its width, with its internal poppets running parallel with thelength. To release fluid from the inflated cylinders, the internalpoppets are actuated so that they move in a direction parallel to thelength, until they open. To achieve this action directly, the opposingsides of the width of the valve housing are compressed. This compressioncauses actuation of the internal poppets.

[0032] In addition, an actuating bar is positioned within the valvehousing parallel with and extending along at least one of the sides ofthe length. An arm attached to the actuating bar extends along a portionof one of the sides of the width in close proximity to the tip of one ofthe poppets. Thus, the configuration of the actuating bar causes it toengage and open the poppet allowing fluid to flow from the cylinder tothe reservoir. Furthermore, the patient can grasp the valve housing invirtually any orientation and when pressure is applied, the actuatingbar will act either directly or indirectly to open the appropriatepoppets. Thus, so long as the patient grasps any portion of the pump andvalve assembly other than the pump bulb, compression will result in thedesired opening of the poppets which allows the cylinders to deflate.

[0033] Furthermore, since the patient can grasp the valve housing alongthe sides of the length, i.e., surfaces with larger surface area, lesspressure need be applied to achieve the successful opening of thepoppets. In other words, by increasing the surface area that is engagedby the patient's fingers and appropriately positioning the actuatingbar, less force need be exerted by the patient to achieve the desiredresult.

[0034] The textured surface of the valve housing not only helps thepatient identify the correct portion of the pump and valve assembly toactuate, it also serves to prevent slippage once the patient begins tocompress the housing. Thus, what is achieved is an efficient andergonomic pump and valve assembly for an implantable prosthesis. Thepump and valve assembly can advantageously be formed from a minimalnumber of components. That is, all that need be molded are a valve blockand a corresponding pump bulb which surrounds the valve block. Thevarious poppets can be inserted into the valve block and then placedwithin the interior of the pump bulb, thus forming a completed assembly.This results in certain manufacturing efficiencies, thus reducing bothcost and time of production.

[0035] To prolong the life of the valve assembly, ribs are added to theactuating bar. The ribs increase the strength and stiffness of theactuating bar and prevent deflection during actuation. Permanentdeformation of the actuating bar is prevented when normal deflectionoccurs during actuation. As a result, full axial motion of the poppet isensured. Another rib is disposed along an actuation face of theactuating bar to also limit deformation during actuation.

[0036] To improve the ease of deflation, a stiff poppet support wrapsaround the valve body and rests against a portion of the check valve.The poppet support has a shelf that provides a smooth surface for aportion of the check valve to slide. The poppet support contacts thecheck valve and prevents undesirable sideways movement of the checkvalve against the valve body. The positioning and configuration of thepoppet support thus allows the check valve to easily move axially intothe valve body to an open position. This results in improved operationalefficiency of the prosthesis pump and an extended operating life.

[0037] In most of the embodiments, the force generated by anoverpressurization of the reservoir is used to prevent fluid flow intothe cylinders.

BRIEF DESCRIPTION OF THE DRAWINGS

[0038]FIG. 1 is a side-sectional view of a penile pump according to theteachings of the prior art.

[0039]FIG. 2 is a side-sectional view of a penile pump wherein thereservoir poppet has been attached to an outer wall of the reservoirchamber.

[0040]FIG. 3 is a side, partially sectional planar view of theattachment mechanism connecting the reservoir poppet to the outer wallof the fluid input chamber.

[0041]FIG. 4 is a side sectional view of housing for a penile pumphaving a tapered reservoir poppet and corresponding passageway whichplugs the fluid input during overpressure situation.

[0042]FIG. 5 is a side sectional view of housing for a penile pumphaving relief areas which expand during an overpressure situation andseal against the reservoir poppet.

[0043]FIG. 6 is a side sectional view of the penile pump in FIG. 5,illustrated during an overpressure situation.

[0044]FIG. 7 is a side sectional view of the penile pump in FIG. 5,illustrated during a compression of the pump bulb.

[0045]FIG. 8 is a side sectional view of the penile pump in FIG. 5,illustrated during a reinflation of the pump bulb.

[0046]FIG. 9 is a side sectional view of the housing of a penile pumphaving relief areas which expand during an overpressure situation, and atermination chamber which cooperates with the cylinder poppet during theoverpressure situation.

[0047]FIG. 10 is a side sectional view of a housing for a penile pumphaving a reservoir poppet coupled to the outer wall of the reservoirchamber via a connecting spring.

[0048]FIG. 11 is a side sectional view of the penile pump of FIG. 10during an overpressurization situation.

[0049]FIG. 12 is a side sectional view of the penile pump of FIG. 10when vacuum forces are generated by the pump bulb.

[0050]FIG. 13 is a side sectional view of the penile pump of FIG. 10when both poppets have been manually opened.

[0051]FIG. 14 is a side sectional view of a housing for a penile pumpwherein the reservoir poppet includes a relatively large biasing springand a large diameter poppet face which abuts the two-spaced lip seals.

[0052]FIG. 15 is a side sectional view of a housing for a penile pumphaving a reservoir poppet that includes a slidable valve seal thatselectively includes a throughbore leading to an outlet in the reservoirpoppet.

[0053]FIG. 16 is a side sectional view of the penile pump illustrated inFIG. 15 during a compression of the pump bulb.

[0054]FIG. 17 is a side sectional view of the penile pump illustrated inFIG. 15 when no forces are being generated.

[0055]FIG. 18 is a side sectional view of the penile pump illustrated inFIG. 15 when both poppets have been manually opened.

[0056]FIG. 18A is a perspective view of an alternate embodiment of apoppet usable in the penile pump in accordance with the presentinvention.

[0057]FIG. 19 is a side sectional view of a penile pump assemblyincluding a conical lip seal and an annular ring that interact with areservoir poppet having a grooved stem and an abutting face.

[0058]FIG. 20 is a side sectional view of the pump assembly of FIG. 19with the cylinder poppet unseated.

[0059]FIG. 20A is a side sectional view illustrating how the reservoirpoppet may be spaced from the annulus to effect fluid flow.

[0060]FIG. 20B is front planar view of an annulus with a plurality ofspacers.

[0061]FIG. 21 is a side sectional view of the pump assembly of FIG. 19while the cylinders are being deflated.

[0062]FIG. 22 is a side sectional view of the pump assembly of FIG. 19while in a deactivated state, which serves to inhibit spontaneousinflation.

[0063]FIG. 23A shows a side view of an alternative embodiment of theentire reservoir poppet including a plastic portion.

[0064]FIGS. 23B and 23C are more detailed illustrations of portions ofthe reservoir poppet, with

[0065]FIG. 23B showing a poppet taper and

[0066]FIG. 23C showing an alternative design.

[0067]FIG. 24 is an exploded perspective view of an alternativeembodiment of the present invention.

[0068]FIG. 25 is perspective view of the actuating bar of the embodimentof FIG. 24.

[0069]FIG. 26A is a top sectional view of the embodiment of FIG. 24.

[0070]FIG. 26B is a top sectional view of the embodiment of FIG. 24showing the elements in a position when both cylinders are inflated.

[0071]FIG. 26C is a top sectional view of the embodiment of FIG. 24showing both valves open.

[0072]FIG. 27 is a perspective view of the poppet support of theembodiment of FIG. 24.

[0073]FIG. 28 is a sectional view of the embodiment of FIG. 24.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

[0074] Referring to FIG. 1, a pump assembly is shown and generallyreferred to as 8. The pump assembly 8, as illustrated in FIG. 1, isessentially that of the prior art, but an understanding of the workingelements of pump assembly 8, as illustrated in FIG. 1, is beneficial tounderstanding the operation of each embodiment of the present invention.Generally, the pump assembly 8 will be implanted into the patient'sscrotum. A separate fluid-filled reservoir (not shown) is implanted insome other portion of the patient's body, usually in the abdomen.Fluidly connecting the reservoir to the pump assembly 8 is fluid input10 which will usually be a flexible silicone tube. A pair of inflatablecylinders (not shown) are usually implanted in the patient's corpuscavernosae and are fluidly connected to pump assembly 8 via fluid output14, which is also usually a flexible silicone tube.

[0075] In general, when pump assembly 8 is actuated, fluid is drawn fromthe reservoir through the pump assembly 8 and pumped into the cylinders.During the inflation process and until released by the patient, the pumpassembly 8 maintains the fluid pressure in the cylinders, thus keepingthem in their inflated state. When deflation is desired, the patientmanipulates assembly 8, permitting fluid to transfer out of theinflatable cylinders and into the reservoir, thereby deflating thecylinders and returning them to a flaccid state.

[0076] Pump assembly 8 generally includes a housing 12 usually formed ofsilicone. Attached to housing 12 is a pump bulb 18, which includes arelatively large pump chamber 36. Fluid input 10 is coupled to thehousing 12 and empties into a reservoir chamber 16. As such, fluid input10 couples reservoir chamber 16 to the reservoir. A common passageway 33is fluidly coupled to reservoir chamber 16 at one end of the housing 12,and is fluidly coupled to fluid output 14 at an opposite end of thehousing 12. Similarly, the pump chamber 36 is fluidly coupled to thecommon passageway 33 via pump passageway 34.

[0077] Disposed within common passageway 33 is a reservoir poppet 20which functions as a check valve. Reservoir poppet 20 is an elongatedmember having a contoured portion which abuts reservoir poppet valveseat 24 forming a fluid tight seal. A reservoir poppet spring 28 engagesreservoir poppet 20 and biases reservoir poppet 20 against the reservoirpoppet valve seat 24. Also disposed within common passageway 33 and inline with reservoir poppet 20 is cylinder poppet 22. Cylinder poppet 22forms a second check valve within common passageway 33. Cylinder poppet22 is biased by cylinder poppet spring 30 against cylinder poppet valveseat 26 in a normal state, thereby forming another fluid tight sealwithin common passageway 33. Reservoir poppet 20 is substantially longerthan cylinder poppet 22. A front end of reservoir poppet 20 extends intoreservoir chamber 16, in close proximity to an outer wall of housing 12.Furthermore, the front end of cylinder poppet 22 is in close proximityto the rear end of reservoir poppet 20. As such, the patient canmanipulate both poppets 20 and 22 by compressing the wall of housing 12.Compression of the housing 12 will cause the reservoir poppet 20 tocompress reservoir poppet spring 28 thus displacing the reservoir poppet20 from reservoir poppet valve seat 24. This motion will also causecylinder poppet 22 to be displaced from cylinder poppet valve seat 26while compressing cylinder poppet spring 30. When both reservoir poppet20 and cylinder poppet 22 are displaced from their respective valveseats, fluid is allowed to freely flow between reservoir chamber 16 andfluid output 14, and hence fluid is allowed to freely flow between thereservoir and the cylinders.

[0078] During a majority of the time, pump assembly 8 will be in theconfiguration shown in FIG. 1. That is, both reservoir poppet 20 andcylinder poppet 22 are abutting their respective valve seats 24 and 26,forming a fluid tight seal. When inflation is desired, pump bulb 18 ismanually compressed by the patient. This forces the fluid in pumpchamber 36 out through pump passageway 34 and into common passageway 33,under relatively high pressure. Because of the location of pumppassageway 34 with respect to the reservoir poppet 20, this increasedpressure causes reservoir poppet 20 to further abut reservoir poppetvalve seat 24. This increased pressure is more than sufficient to removecylinder poppet 22 from its abutment with cylinder poppet valve seat 26,by compressing cylinder poppet spring 30. As such, the pressurized fluidis allowed to pass through a portion of the common passageway 33 andinto fluid output 14, where it eventually reaches an inflatablecylinder. When released, the pump bulb 18 expands back to its originalconfiguration, creating negative pressure within pump chamber 36 andcommon passageway 33. This negative pressure draws cylinder poppet 22towards valve seat 26 and simultaneously pulls reservoir poppet 20 awayfrom valve seat 24. As such, fluid is drawn from the reservoir and intopump chamber 36 until the negative pressure is eliminated. Then,reservoir poppet spring 28 causes the reservoir poppet 20 to reseatitself against valve seat 24.

[0079] Repeated compression of pump bulb 18 eventually inflates thecylinders to a sufficient degree of rigidity for the patient. Onceinflated, the fluid remaining in fluid output 14 is under a relativelyhigh degree of pressure. This high pressure fluid aids cylinder poppetspring 30 in forcing cylinder poppet 22 against cylinder poppet valveseat 26 again forming a fluid tight seal and preventing fluid fromwithin the cylinders from passing through (preventing deflation of thecylinders).

[0080] When the patient desires deflation of the cylinders, the wall ofhousing 13 is manually compressed. This compression forces reservoirpoppet 20 away from reservoir poppet valve seat 24 and simultaneouslycauses cylinder poppet 22 to be removed from cylinder poppet valve seat26. The pressurized fluid within the cylinders and fluid output 14naturally returns to the reservoir via common passageway 33.Furthermore, the cylinders can be manually compressed forcing out anyremaining fluid. Once the cylinders are satisfactorily emptied, thepatient releases the grip on housing 12, thus allowing cylinder poppet22 and reservoir poppet 20 to once again abut their respective valveseats 24 and 26.

[0081] As described above, pump assembly 8 (as shown in FIG. 1) worksrelatively well under normal circumstances. However, when the patientcompresses the reservoir inadvertently through bodily movement, thepressure generated may be sufficient to remove reservoir poppet 20 andcylinder poppet 22 from their respective valve seats 24 and 26, thusspontaneously inflating the cylinders. When sufficient force isgenerated against the reservoir (or a similar component) to cause thefluid pressure to exceed the resistive characteristics of poppets 20 or22, an overpressure situation has occurred. Of course, the only way torelease this spontaneous inflation is to manually release the checkvalves.

[0082] To date, it has been very difficult to monitor and determine thepressures generated in an overpressure situation since each patientexhibits unique individual characteristics. Furthermore, eachspontaneous inflation may result from a very different physical act onthe part of the patient. However, it appears that pressure generated bycompression of the reservoir results in a fluid pressure of up to 3pounds per square inch (1.361 kg/25.4² mm) but may be as high as 6-8pounds per square inch (2.722 kg/25.4² mm). Conversely, compression ofthe pump bulb 18 will usually generate pressures on the order of 20pounds per square inch (9.072 kg/25.4² mm).

[0083] Referring to FIG. 2, a first embodiment of the present inventionis illustrated. A fluid input 10 couples a reservoir to reservoirchamber 16. Reservoir poppet 20 has been modified to include a T-shapedtip 70. Tip 70 is secured to an outer reservoir chamber wall 72. Tip 70is secured to the outer reservoir chamber wall by one or more connectingbands 74. Sufficient freedom of movement for reservoir poppet 20 isprovided so that during normal operation reservoir poppet 20 can bedislodged from its abutment with reservoir poppet valve seat 24.

[0084] During an overpressure situation, the reservoir is compressed,pressurizing the fluid and directing it through fluid input 10 and intoreservoir chamber 16. Outer reservoir chamber wall 72 has been madesufficiently flexible so that when this occurs, reservoir chamber 16 iscaused to expand due to the increased pressure generated. As outerreservoir chamber wall 72 expands, connecting bands 74 coupled with tip70 pull reservoir poppet 20 tightly against reservoir poppet seat 24.The overpressurization generated by the reservoir is used against itselfto prevent fluid from reaching the cylinders and creating a spontaneousinflation.

[0085] Referring to FIG. 3 a side partially sectional view is shownwhich helps illustrate the interior side of outer reservoir chamber wall72. Tip 70 of reservoir poppet 20 is secured at each end by a connectingband 74 which overlaps tip 70 and is interconnected with outer reservoirchamber wall 72. Any interconnection of tip 70 or reservoir poppet 20 toouter reservoir chamber wall 72 is acceptable so long as during anoverpressurization situation, reservoir poppet 20 is pulled againstreservoir poppet valve seat 24 and during normal use sufficientflexibility is provided so that reservoir poppet 20 can be displacedfrom reservoir poppet valve seat 24 allowing the desired fluid flow.

[0086] Referring to FIG. 4, a second embodiment of the present inventionis illustrated. FIG. 4 illustrates the portion of housing 12 containingreservoir poppet 20 and cylinder poppet 22. Reservoir poppet 20 is anelongated member that terminates in a nose 82. A tapered reservoirpassageway 84 is provided through a sidewall 80 located adjacent tofluid input 10. Located at the junction of the sidewall 80 and reservoirpassageway 84 is a flap 78 that is able to flex, with respect tosidewall 80. Flap 78 is simply the terminus of sidewall 80 at thepassageway 84, and will optimally be offset by some angle from theremainder of the sidewall 80.

[0087] As illustrated in FIG. 4, reservoir poppet 20 is in a sealedposition. That is, fluid is not able to pass from fluid input 10 throughtapered passageway 84 and beyond, because reservoir poppet 20 is sealedagainst sidewall 80 at reservoir poppet valve seat 24 and is held inplace by spring 28. In addition, nose 82 of reservoir poppet 20 contactsflap 78, providing a further seal. The remainder of passageway 84 isopen between reservoir poppet 20 and sidewall 80.

[0088] In normal use, reservoir poppet 20 is pulled away from its sealedposition by a vacuum created at pump passageway 34. This allows fluid topass from fluid input 10, through passageway 84, and then through commonpassageway 33 into pump bulb 18. During a compression of pump bulb 18,reservoir poppet 20 is further pressed against valve seat 24.

[0089] During an overpressure situation, the fluid pressure in thereservoir and hence within fluid input 10 will increase. This increasedpressure is applied evenly within fluid input 10, however flaps 78 areable to give in response to these forces. As such, flap 78 will beforced against a portion of reservoir poppet 20. The shape of reservoirpoppet 20 and passageway 84 are chosen so that as flap 78 is pressedagainst reservoir poppet 20, a strong seal is formed. In other words,sufficient give is provided in sidewall 80, particularly at and behindflap 78 (due to its shape and flexibility) so that increased pressurecauses a fluid tight encasement of poppet 20 rather than a displacementof poppet 20. Therefore, reservoir poppet 20 remains sealed andspontaneous inflation is prevented. While one specific configuration ofthis concept is shown in FIG. 4, it is to be understood that a widevariety and combinations of the disclosed teachings may be used whileachieving the same result. The shape of the reservoir poppet 20,passageway 84, and the location and shape of flap 78 are extremelyvariable so long as these elements work together to form a fluid tightseal during an overpressure situation.

[0090] Referring to FIG. 5, a third embodiment is illustrated. Reservoirpoppet 20 is an elongated member that extends from common passageway 33,through poppet passageway 92 and into fluid input 10. As with many ofthe above embodiments, in one position the reservoir poppet 20 abutsreservoir poppet valve seat 24. Similarly, reservoir poppet 20 is onlyexpected to be removed from valve seat 24 during a re-expansion of acompressed pump bulb 18. To prevent the removal of the reservoir poppetfrom valve seat 24 during an overpressure situation, relief area 90 hasbeen formed within the housing 12. Formation of relief area 90 creates aflexible valve 88. Flexible valve 88 forms a part of the reservoirpoppet valve seat 24, and appears as shown in FIG. 5, under normalcircumstances.

[0091]FIG. 6 illustrates an overpressure situation where the pressure ofthe fluid in fluid input 10 and poppet passageway 92 is relatively high.Rather than forcing reservoir poppet 20 from valve seat 24, thisoverpressure causes relief area 90 to expand; which in turn causesflexible valve 88 to even more firmly abut reservoir poppet 20.Depending upon the particular arrangement chosen, such an expansion ofrelief area 90 may cause some compression of reservoir poppet spring 28.In other words, reservoir poppet 20 is caused to move towards thecylinder poppet 22. Such motion will normally allow a spontaneousinflation to occur. However, in this embodiment, it is the movement ofvalve seat 24 that moves reservoir poppet 20, as such, a fluid seal isnot only maintained, it is made stronger. To further support reservoirpoppet 20, nose 46 of cylinder poppet is located in close proximity tothe rear of reservoir poppet 20. As such, when expansion of relief area90 causes a small amount of movement of reservoir poppet 20, reservoirpoppet 20 is caused to abut cylinder poppet 22. Therefore, any furthermovement of reservoir poppet 20 requires compression of both reservoirpoppet spring 28 and cylinder poppet spring 30. This combination ofspring forces provides a relatively high resistive force opposingfurther movement of reservoir poppet 20, even during an overpressuresituation. This combined with the expandable characteristics of reliefarea 90 prevents a spontaneous inflation from occurring. Of course, therelief area 90 can be fashioned to prevent such spontaneous inflationwithout causing the reservoir poppet 20 to engage cylinder poppet 22.

[0092]FIG. 7 illustrates a state where pump bulb 18 is being compressed,forcing fluid around cylinder poppet 22 and out through cylinder poppetoutput 32. Simultaneously, reservoir poppet 20 is forced towards fluidinput 10, causing flexible valve 88 to collapse against the innerportions of relief area 90. Once again, the strength of the seal atvalve seat 24 is increased during such movement.

[0093] Immediately after the state shown in FIG. 7 occurs, pump bulb 18is released. As illustrated in FIG. 8, this creates a vacuum which pullscylinder poppet 22 against cylinder poppet valve seat 26 and pullsreservoir poppet 20 away from valve seat 24; thus allowing fluid fromthe reservoir to flow into pump bulb 18. Flexible valve 88 is createdwith sufficient rigidity to resist being forced against reservoir poppet20 while fluid is flowing through poppet passageway 92 and into pumpbulb 18. Furthermore, the previous compression of flexible valve 88against poppet 20 (FIG. 7) substantially evacuates relief area 90.Therefore when reservoir poppet 20 is initially pulled from valve seat24, relief area 90 will remain in an evacuated state while fluid flowbegins. The system is configured so that relief area 90 will not totallyfill (and expand) with fluid and seal against reservoir poppet 20 untilpump bulb 18 has been refilled. This can be done by making flexiblevalve 88 too rigid to allow such a seal to be formed in this state;providing for a sufficient amount of reservoir poppet 20 movement toprevent the flexible valve 88 from reaching poppet 20, even when reliefarea 90 is completely expanded; or simply imparting sufficient rigidityin flexible valve 88 so that the time is takes to expand relief area 90is greater than the time it takes to refill pump bulb 18.

[0094]FIG. 9 illustrates a fourth embodiment utilizing a combinedsolution to avoid spontaneous inflation. Namely, relief area 90 has beenprovided and works as described above. In addition, bypass passageway 38has been provided which fluidly connects fluid input 10 to terminationchamber 40. Termination chamber 40 includes abutting wall 42, which actsas a diaphragm when an overpressure situation occurs. These twomechanisms will act in concert to prevent a spontaneous inflation fromoccurring. One advantage of this arrangement is that nose 46 of thecylinder poppet 22 will be displaced towards the rear of reservoirpoppet 20 via an expansion of termination chamber 40. This force opposesthe movement of the reservoir poppet 20, in the opposite direction thatis generated from an expansion of relief area 90. In essence, the forcegenerated by the overpressure is caused to directly oppose itself, whichin turn prevents spontaneous inflation.

[0095] Referring to FIG. 10, a fifth embodiment to the present inventionis illustrated. Housing 12 includes a fluid input 10 that is in fluidcommunication with fluid output 14 through a reservoir chamber 16 and acommon passageway 33. Common passageway 33 is selectively occluded by areservoir poppet 20 and cylinder poppet 22 which are both biased towardsa closed position. A portion of reservoir poppet 20 is physicallyconnected to a connection spring 100. The opposite end of connectionspring 100 is attached to a wall 13 of housing 12. Connections to spring100 are biased to maintain the configuration illustrated in FIG. 10.

[0096]FIG. 11 illustrates what occurs during an overpressurizationsituation. As increased fluid pressure is generated, wall 13 inreservoir chamber 16 is caused to expand outward as indicated by thearrows. Since connection spring 100 is fixedly attached to wall 13, thetension generated by expanding spring 100 serves to pull reservoirpoppet 20 firmly against valve seat 24, creating an even more fluidtight seal.

[0097] Once pump bulb 18 has been compressed and released, vacuum forcesare generated which unseat reservoir poppet 20. This situation isillustrated in FIG. 12. Thus, despite an overpressurization situationwherein wall 13 is expanded outwardly and connection spring 100 ispulling against reservoir poppet 20, the vacuum forces generated, aresufficient to unseat reservoir poppet 20 and allow fluid flow into pumpbulb 18 (as shown by flow arrows A).

[0098] When so desired, wall 13 is compressed causing reservoir poppet20 to unseat itself and contact cylinder poppet 22 which, in turn,unseats that valve as well. Thus, fluid from the cylinders can bereturned to the reservoir. This situation is illustrated in FIG. 13 andillustrates how the interaction of connection spring 100 and reservoirpoppet 20 will facilitate this movement.

[0099] Referring to FIG. 14, a sixth embodiment of the present inventionis illustrated. A biasing spring 105, exerting a large amount of force,is coupled to reservoir poppet 20 keeping it in its closed position.Because of the large amount of force being exerted, biasing spring 105will be able to resist high forces generated during anoverpressurization situation and, thus, preventing spontaneousinflation.

[0100] Because biasing spring 105 is significantly stronger than thosein the previous embodiments, it also makes it harder to open reservoirpoppet 20 with the level of vacuum forces generated by the pump bulb 18.To overcome this issue, poppet face 110 is made significantly largerthan in the previous embodiments. That is, the surface area of poppetface 110 has a diameter that approximates the diameter of intermediatechamber 107, which houses reservoir poppet 20. Though the amount ofpressure generated by the suction of release pump bulb 18 will be fixed,by increasing the surface area of poppet face 110, the negative forcegenerated will be greatly increased and will allow biasing spring 105 tobe overcome.

[0101] As illustrated, the portion of housing 12 in contact with poppetface 110 when reservoir poppet 20 is closed, is not simply a planarconfiguration. As a practical matter, it is too difficult to manufacturea planar surface which will flushly and repeatedly coact with a planarpoppet face 110 to consistently form a fluid-tight seal. Instead, a pairof flexible lip seals is provided. That is, inner lip seal 115 and outerlip seal 120 are provided and define a recessed portion 125 betweenthem. Outer lip seal 120 contacts an outer portion of poppet face 110preventing suction forces from interacting with the rear portion ofpoppet face 110 and holding it in place during a refilling of pump bulb18. Inner lip seal 115 prevents fluid pressure generated during anoverpressurization situation from acting against a majority of poppetface 110, which would otherwise eliminate much of the benefit of havinga larger biasing spring 105. Lip seal 115 acting in conjunction with theforces generated by biasing spring 105 allows poppet face 110 to form afluid-tight seal despite any irregularities in either poppet face 110 orhousing 112. During an overpressurization situation, pressurized fluidfrom reservoir chamber 16 interacts with only a very small area ofpoppet face 110. The force generated will be insufficient to movebiasing spring 105, thus, reservoir poppet 20 will remain in the sealedposition preventing spontaneous inflation.

[0102] Referring to FIG. 15, a seventh embodiment of the presentinvention is illustrated. Once again, a reservoir poppet 20 and cylinderpoppet 22 are provided to selectively occlude a common passageway 33between a reservoir chamber 16 and a fluid output 14. As in the previousembodiments, a front face 150 of reservoir poppet 20 abuts valve seat 24to prevent fluid flow from reservoir chamber 16. In this embodiment thisoccurs in two different situations. That is during a compression of pumpbulb 18 (as illustrated in FIG. 16) and during an unused situation whenno overpressurization is occurring (as illustrated in FIG. 17).

[0103] Extending behind front face 150 is a rear section 137 of poppet20. At least a portion of rear section 137 is hollow and is in fluidcommunication with throughbore 140 (a plurality of throughbores 140 canalso be provided). Outlet 145 forms a terminus of rear section 137 andis also in fluid communication with the hollowed out portion. A valvesleeve 130 slides over rear section 137 and is held in a spacedrelationship from front face 150 by slide spring 135 which biases frontface 150 away from valve sleeve 130. The movement of valve sleeve 130with respect to rear section 137 selectively seals and unsealsthroughbore 140.

[0104] As illustrated in FIG. 17, under normal conditions valve sleeve130 is abutting a portion of housing 12. Slide spring 135 biases frontface 150 of poppet 20 against valve seat 24. In this situation, it isfront face 150 that prevents fluid flow from reservoir 16.

[0105] During an overpressurization situation, as illustrated in FIG.15, the forces generated within reservoir chamber 16 serve to unseatfront face 150 causing it to move away from valve seat 24. To accomplishthis, slide spring 135 must be at least partially compressed. In otherwords, overpressurization forces must be sufficient to compress slidespring 135 to cause this to occur. As front face 150 is unseated, rearsection 137 moves through valve sleeve 130, since valve sleeve 130 ispressed firmly against a portion of housing 12. This action causesthroughbore 140 to be occluded by valve sleeve 130. Therefore, eventhough pressurized fluid is able to enter into chamber 107, it is unableto pass through valve sleeve 130 and enter throughbore 140.Consequently, pressurized fluid never reaches cylinder poppet 22 and is,therefore, unable to unseat it and cause spontaneous inflation.

[0106] During compression of the pump bulb 18 (FIG. 16), pressurizedfluid enters intermediate chamber 107 forcing front face 150 to firmlyabut against valve seat 24. At the same time valve sleeve 130 is pressedfirmly against its respective portion of housing 12. Since valve sleeveand front face 150 are spaced at their maximum distance, throughbore 140is exposed and pressurized fluid from pump bulb 18 is able to passthrough and unseat cylinder poppet 22 leading to an inflation of thecylinders.

[0107]FIG. 18 illustrates how a manual release of a reservoir poppet 20can unseat both the reservoir poppet 20 and cylinder poppet 22 allowingfor deflation of the cylinders. Sleeve 130 is forced toward front face150 by the pressure in the cylinders once cylinder poppet 20 isunseated.

[0108] Referring to FIG. 18A, a poppet 20′ is disclosed that canalternatively be incorporated into previous embodiments of the inventionin place of poppet 20. The alternative poppet 20′ includes a pluralityof flutes 145′ that loosely correspond in function to the output 145discussed previously. Similarly, the lower, curved ends 140′ of theflutes 145′ loosely correspond in function to the throughbore 140discussed previously.

[0109] Referring to FIGS. 19-22, an eighth embodiment of the presentinvention is illustrated. Housing 12 includes common passageway 33 thatfluidly couples reservoir chamber 16 to fluid output 14 and is fluidlycoupled to pump passageway 34. Housing 12 also includes a taperedreservoir poppet valve seat 24 configured to interact with a similarlytapered front face 210 of reservoir poppet 20. An annulus 205 is formedwithin housing 12 and is spaced away from, but proximate to, valve seat24. Annulus 205 is configured to provide an opening 207 that is slightlysmaller than front face 210. Annulus 205 is a semi-rigid portion ofhousing 12 that allows passage of front face 210 through opening 207 bymoderate deflection. In other words, even though front face 210 isslightly larger than opening 207, it can still be forced therethrough.Comparing FIG. 19 with FIG. 21 also sees this relationship.

[0110] Housing 12 also includes a conical lip seal 200, which ispositioned just forward of cylinder poppet 22. Conical lip seal 200 is aflexible member that interacts with a stem 215 of reservoir poppet 20.Stem 215 is generally cylindrical and includes a V-shaped groove 220extending around its circumference. Groove 220 thus defines a medialstem section 225 that lies between groove 220 and front face 210. Medialstem section 225 is generally cylindrical.

[0111] Reservoir poppet 20 can be placed into three distinctconfigurations that define an activated state, a deactivated state, anda draining or open state. In the activated state (FIG. 19), pump bulb 18can be used to inflate the cylinders. Reservoir poppet 20 is alsomaintained in the activated state while the cylinders are to remaininflated. In the draining state illustrated in FIG. 21, the cylinderscan be emptied. Reservoir poppet 20 is placed in the deactivated stateduring periods of nonuse to prevent spontaneous inflation.

[0112]FIG. 19 illustrates pump assembly 8 in the activated state. Frontface 210 is positioned between annulus 205 and valve seat 24. When sopositioned, reservoir poppet spring 28 biases front face 210 againstvalve seat 24. If pump bulb 18 is compressed, the fluid pressuregenerated reinforces the biasing action of reservoir poppet 20, andcauses front face 210 to further abut valve seat 24. At the same time,cylinder poppet 22 is unseated and fluid is forced into the cylinders.When reservoir poppet 20 is so positioned, V-shaped groove 220 isaligned with conical lip seal 200. This effectively prevents conical lipseal 200 from interfering with fluid flow in either direction. That is,the configuration of conical lip seal 200 is such that it cannoteffectively prevent fluid flow in a direction from cylinder poppet 22towards reservoir chamber 16. Fluid flow in the opposite direction isalso unhindered (in the activated state) because groove 220 permitsfluid pressure levels to increase “underneath” conical lip seal 200(i.e., between lip seal 200 and stem 215), thus fluid flow is permittedfrom pump chamber 36 to the cylinders. FIG. 19 illustrates thisconfiguration during a compression of pump bulb 18.

[0113]FIG. 20 illustrates the configuration of the components during arelease of pump bulb 18. The vacuum generated works with the biasingforce of cylinder poppet spring 30 to cause cylinder poppet 22 to seal.The vacuum forces also cause front face 210 to be pulled away from valveseat 24. This allows fluid to flow from reservoir chamber 16 into pumpchamber 36. While the vacuum forces are sufficient to unseat front face210, they are insufficient to cause it to pass through annulus 205;thus, back face 211 of reservoir poppet 20 abuts annulus 205 or(depending on the spring forces involved) is held between annulus 205and valve seat 24. In either case, fluid as able to flow into pumpchamber 36. After a number of compressions of pump bulb 18, the cylinderwill be inflated. While the cylinders are to remain inflated, pumpassembly 8 is kept in the activated state.

[0114] During a release of pump bulb 18, the vacuum forces generated maybe sufficient to cause back face 211 to seal against annulus 205. Ifthis occurs, the pump assembly may lock up and remain in this position.That is, pump bulb 18 will be at least partially compressed and thevacuum generated will be sufficient to keep reservoir poppet 20 sealedagainst annulus 205, preventing fluid from moving from the reservoir topump chamber 36. All that need be done to relieve the vacuum is manuallycompress the sidewall to cause reservoir poppet 20 to unseat.

[0115] This situation may be confusing to patients and they may notrealize the nature of the problem. Thus, a modified annulus 205 (and/ora variation in reservoir poppet 20) can be provided to prevent thesituation from occurring. Referring to FIGS. 20A and 20B, such amodified annulus 205 is illustrated. Annulus 205 includes a number ofspacers 213 positioned about annulus 205 and facing valve seat 24.Spacers 213 are positioned so that when rear face 211 is in contact withthem, there is still a fluid path around reservoir poppet 20 and throughannulus 205. That is, there is never an opportunity for rear face 211 toseal against annulus 205.

[0116] The nature and number of spacers 213 can vary. Providing threespacers allows full support of rear face 211. That is, rear face 211 isnot caused to pivot by only being supported at one or two points. Thispivoting action is not necessarily detrimental, and one or two spacers213 could be utilized. More could also be utilized, so long assufficient fluid flow is permitted. The actual size and shape of spacers213 will depend upon the methods utilized to form them. Any size, shapeand configuration is permissible so long as fluid flow sufficient toprevent the above described vacuum lock is permitted. Finally, spacers13 could be attached to rear face 211 rather than annulus 205 to permitappropriate fluid flow.

[0117] Alternatively, various other methods could be employed to achievethe same result. So long as fluid flow around rear face 211 and throughannulus 205 is permitted, this potential problem is avoided. There aresolutions other than providing spacers. For example, one or more groovescould be cut into rear face 211 to achieve the same result. Variousother access ports or passageways could likewise be provided. Of course,these various techniques could be combined in any number of ways.

[0118] After use, when the operator wishes to deflate the cylinders, thesidewalls of housing 12 are compressed. This forces reservoir poppet 20to move from the activated position, past the deactivated position (asshown in FIG. 22) and into the draining state, by causing front face 210to move through annulus 205 to the position illustrated in FIG. 21.Furthermore, this movement of reservoir poppet 20 causes it to engagecylinder poppet 22 and unseat it as well as moving front face 210 awayfrom annulus 205. Fluid is then able to flow from the cylinders into thereservoir.

[0119] When the cylinders are satisfactorily deflated, housing 12 isreleased. Referring to FIG. 22, reservoir poppet spring 28 biases frontface 210 against annulus 205. As shown, reservoir poppet 20 is in thedeactivated position. In this position, conical lip seal 200 engagesmedial stem section 225, which is cylindrical in nature and approximatesconical lip seal 200 in size and shape. Should a compression of thereservoir cause an overpressure situation, increased fluid pressure willforce reservoir poppet 20 to be moved back from annulus 205 and allowreservoir pressure to enter intermediate space 300. Without lip seal200, reservoir pressure would enter common passageway 33 and opencylinder poppet 22 causing spontaneous inflation. However, reservoirpressure will act on conical lip seal 200 causing it to firmly sealagainst medial stem section 225, thus preventing fluid pressure fromacting on cylinder poppet 22 and thus preventing spontaneous inflation.

[0120] The operator must place pump assembly 8 in the deactivated stateduring periods of non-use to effectively prevent spontaneous inflation.When the operator desires to inflate the cylinders and pump assembly 8is in the deactivated state, all that is required is a compression ofpump bulb 18. As pump bulb 18 is compressed, fluid pressure levelswithin intermediate space 300 are rapidly increased to relatively highlevels. Conical lip seal 200 continues to prevent fluid flowtherethrough (thus preventing an unseating of cylinder poppet 22);however, the higher pressures being generated are sufficient to forcefront face 210 through annulus 205. Thus a compression of pump bulb 18causes reservoir poppet 20 to move from the deactivated position to theactivated position, from which the cylinders are inflated in the abovedescribed manner.

[0121] FIGS. 23-28 illustrate alternative embodiments of a reservoirpoppet 318 and a pump and valve assembly 300 in which certainmodifications have been made to improve performance. The functionalityand operability of the arrangement of FIGS. 23-28 is discussed inco-pending application Ser. No. 09/749,075 entitled “Penile Pump WithSide Release Mechanism” which was filed on Dec. 27, 2000, and Ser. No.______ entitled “Improved Penile Pump With Side Release Mechanism,”(Attorney-Docket No. AMS-040) filed concurrently herewith, the entiredisclosure of which is herein incorporated by reference.

[0122] As shown in FIG. 23A, a reservoir poppet 318 comprises anelongate rigid member 260 and a synthetic member 262. Synthetic member262 is disposed over a segment/post portion 264 of the rigid member 260.Rigid member 260 is preferably made of a metal material, such as steel,stainless steel, or the like. Synthetic member 262 is preferably made ofa strong, durable plastic material, for example, acetal, nylon and/orpolyester, to prevent undesired frictional contact with another metalmember, such as an actuating bar described below. Synthetic member 262is rigidly attached to rigid member 260 by molding, bonding, or thelike. Synthetic member 262 prevents premature wearing of reservoirpoppet 318 and another member. For example, synthetic member 262 mayprevent direct metal-on-metal contact of metal reservoir poppet 318 withan actuation bar 310, as shown in FIG. 24. The addition of syntheticmember 262 reduces the frictional interaction of reservoir poppet 318and another metal member, which typically occurs at an end 266 ofreservoir poppet 318. Thus, the risk of marking or deforming reservoirpoppet 318 and the engaging metal member is reduced, and the useful lifeof the two components is extended.

[0123] As disclosed in the embodiments of FIGS. 19-22 above, V-shapedgroove 220 is sized and shaped to operably associate with lip seal 200to prevent lip seal 200 from interfering with fluid flow atpredetermined relationships between the poppet 318 and lip seal 220. Asshown in the embodiment of FIG. 23B, poppet 318 has a poppet taper 777.In operation, when poppet 318 is pushed back into the release ordeflation mode (see FIG. 26C), taper 777 permits lip seal 200 toseparate from poppet 318. This allows fluid from the cylinder to passunimpeded through the pump. Without taper 777, lip seal 200 would reston reservoir poppet 318 as shown in FIG. 23C. The arrangement of FIG.23C requires pressure to open lip seal 200 before fluid is allowed topass from the cylinder to the reservoir. Moreover, when the pressuredrops below a minimum value, lip seal 200 closes on poppet 318 and trapspressurized fluid in the cylinder. This typically happens at a less thanflaccid cylinder condition. Unfortunately, to force this pressurizedfluid out of the cylinder when it is at this state, the patient mustsqueeze his penis and the cylinder to increase cylinder pressure andopen the lip seal design. For these reasons, the embodiment shown inFIG. 23C is a less preferred design.

[0124] As discussed in the embodiments above, in some patients it may bedifficult to achieve compression because of the relatively small size ofpump bulb 18. Likewise, it may be difficult for certain patients tograsp valve housing 12 in the proper manner since valve housing 12 mayslip out of position between the patient's fingers. Thus, an alternativepump and valve assembly 300 is provided as shown in FIGS. 24-28.

[0125]FIG. 24 shows an exploded view of the alternative pump and valveassembly 300 with an actuating bar 310, a pump bulb 316, a reservoirpoppet 318, and a poppet support 320. Assembly 300 comprises a valveblock 317 for housing the fluid passageways that inter-connectinflatable cylinders and a reservoir (not shown), as discussed in theembodiments above. Actuating bar 310, having a plurality of ribs 328 and330, attaches to a side of valve block 317 and is positioned to engagean end of a reservoir poppet 318. Reservoir poppet 318 is a check valvethat operates to control fluid flow into and out of a reservoir, and isto be positioned within fluid passageways of valve block 317. Poppetsupport 320 is to be disposed on an end of valve block 317, proximate anend 266 of reservoir poppet 318, to prevent sideways sliding ofreservoir poppet 318 during actuation of the pump. Pump bulb 316 is tobe located over the valve block 317, actuating bar 310, reservoir poppet318, and poppet support 320. Pump bulb 316 comprises major panels 312and 314 with textured surfaces that allow patients to easily identifythat portion of the valve assembly 300. When a patient applies pressureto major panels 312 and 314 of pump bulb 316, major panel 312 engagesactuating bar 310. This allows the patient to grasp the major panels 312and 314 to cause actuating bar 310 to force reservoir poppet 318 to moveto an open position, permitting the flow of fluid through the channelsof valve block 317. Actuating bar 310 and poppet support 320 aredescribed in detail below.

[0126] Preferably, reservoir poppet 318 of the embodiment of FIG. 24 issubstantially the same as hybrid metal and synthetic reservoir poppet318 disclosed in FIG. 23A and discussed above.

[0127] As illustrated in FIGS. 24-26, actuating bar 310 is a thinelongated member formed to comprise an actuating face 322 and anactuating arm 324 that are connected by an angle portion 326. A U-shapedportion 332 connects a connecting end 338 to actuating face 322.

[0128] Connecting end 338 includes two forked portions 666, one of whichis shown in FIG. 25. As shown in FIG. 26A, actuating bar 310 is disposedwithin valve block 317 by securement of end 338 into a valve blockinterface 336. The forked portions 666 of connecting end 338 help holdactuating bar 310 in place.

[0129] Angle portion 326 provides actuating bar 310 with a spring forcethat is applied to an end 266 of reservoir poppet 318. Angle portion 326permits actuating face 322 of actuating bar 310 to extend along thelength of valve block 317 while actuating arm 324 extends along a sideof the width of the valve block 317. The configuration of actuating bar310 enables it to engage an end 266, e.g., the tip, of reservoir poppet318. Actuating arm 324 includes a curved portion 325 for complementaryengagement with reservoir poppet end 266. Preferably, curved portion 325presents a smooth face to the side of the pump shell when the pump shellacts on the curved portion 325 of the actuating bar 310.

[0130] As discussed above, when the patient grasps the valve assembly invirtually any orientation and applies pressure (e.g. see FIG. 26C),actuating bar 310 acts to open the appropriate check valves. Thus, whenthe patient grasps a portion of the pump and valve assembly 300 otherthan the pump bulb 316, compression will result in the flexing ofactuating bar 310. During compression, actuating face 322 flexesinwardly and actuating arm 324 flexes toward poppet end 266, asindicated by arrow A in FIG. 26A. Actuating arm 324 moves intoengagement with poppet end 266. The movement of actuating arm 324 forcesaxial movement of reservoir poppet 318 in the same direction as arrow Aand into an open position. The axial movement of the reservoir poppet318 permits fluid to flow through the fluid pathways to the reservoirand allows the cylinders to deflate (FIG. 26C).

[0131] When the patient ceases compression of pump and valve assembly300, actuating face 322 returns to its original position. Actuating arm324 moves in a direction indicated by arrow B, and out of engagementwith poppet end 266. This motion permits reservoir poppet 318 to moveinto the deactivated position, as shown in FIG. 26A.

[0132] Angle portion 326 in actuating bar 310, and its resistance toflexing outwardly, creates a desirable spring force member. This springis the mechanism that forces reservoir poppet 318 into a position thatpermits the flow of fluid through the fluid pathways and back into thereservoir. For example, during patient compression of pump and valveassembly 300 (FIG. 26C), actuating arm 324 enters engagement with poppetend 266. Actuating arm 324 applies the spring force to the poppet end266 to force reservoir poppet 318 into the interior of valve block 317into an open position. When actuating arm 324 is engaged with poppet end266, there is an opposing force created by the resistance of reservoirpoppet 318 to movement toward the open position. This opposing force mayovercome the spring force and cause actuating arm 324 to improperlydeflect. Stated alternatively, this improper deflection occurs when theopposing force exerted against the spring force of actuating bar 310overcomes the inherent spring force and causes the actuating arm 324 tobend backwards or buckle.

[0133] To prevent improper deflection, ribs 328 are formed on actuatingbar 310, as shown by FIG. 25. Each rib 328 is a recess or impressionformed in actuating bar 310 and extends across angle 326. Ribs 328increase the strength and stiffness of angle portion 326, whichincreases the resistance to deflection during actuation. The surfacearea of angle portion 326 is disposed along a given plane. Ribs 328divide the surface area of angle portion 326 with recesses that extendinto another plane. The portions of material extending in a differentplane increase the spring force of angle portion 326. This increase inspring force decreases the likelihood of improper deflection ofactuating arm 324. The absence of improper deflection thus ensures fullaxial travel of reservoir poppet 318 and attainment of the openposition. Additionally, reinforcement of angle portion 326 prevents anypermanent deformation that might occur due to repeated actuation. Thisresistance to deflection or bending helps prevent fatigue of actuatingbar 310 and extends the useful life of the component. Although ribs 328may be formed by a curved recess that extends in a plane perpendicularto the surface of angle portion 326 as shown in the Figures, ribs 328may exist in many different orientations. A sufficient number of ribs328 may be provided to angle 326 so as to achieve a predetermineddeflection resistance. For example, two ribs 328 are provided in theangle 326, as shown in FIG. 25.

[0134] When a patient compresses valve assembly 300 to deflate theprosthesis, actuating face 322 flexes or pivots inwardly about U-shapedportion 332. This causes actuating face 324 to move into engagement withpoppet end 266. The repeated application of force to a particular areaof actuating face 322, may cause permanent deformation. As shown in FIG.25, a recess formed in and disposed along actuating face 322 defines arib 330. Rib 330 strengthens and stiffens actuating face 322 to limitdeformation. Rib 330 extends into a plane other than the plane createdby the surface of actuating face 322 to increase its resistance tobending. During patient compression, rib 330 distributes the forceapplied throughout actuating face 322 rather than permit the compressionforce to be concentrated in one area. Thus, actuating face 322 properlyflexes while resisting permanent deformation. Rib 330 may be shaped todistribute the compression force in any desired pattern. For example, asshown in FIG. 25, rib 330 may be a spoon-shaped impression centrallyformed on actuating face 322 with a larger oval portion disposed towardU-portion 332 of actuating bar 310. An elongate portion 334 ofspoon-shaped rib 330 extends toward angle portion 326. This shape ispreferred since rib 330 helps to lower stresses and reduce deflectioncaused by compression forces applied to flex actuating face 322.

[0135] The relatively thin composition of actuation bar 310 isbeneficial for several reasons. During actuation, U-portion 332 bends toflex actuating face 322 inwardly and actuating face 322 moves actuatingarm 324 into engagement with reservoir poppet 318. After actuation,U-portion 332, actuating face 322 and actuating arm 324 return to theiroriginal position. With an actuating bar made of a thick material,U-portion 332 does not properly bend during actuation. In operation,when using a thicker actuating bar 310 U-portion 332 does not bend, andconnecting end 338 is pushed into valve block 317 causing its innercavities to distort. In turn, this causes annular ring 500 (FIG. 26) ofvalve block 317 to come out-of-round and impedes or stops the movementof poppet 318 in direction A. Preferably, actuating bar 310 is a thinmember made of a material with a sufficient thickness and stiffness toprovide the desired spring force and avoid improper deflection. Forexample, actuation bar 310 may be formed from a stainless steel sheethaving a thickness of approximately 0.010 inches. Actuation bar 310 maybe made of various metal materials, plastic, or the like.

[0136] As shown in FIG. 26C, the engagement of actuating arm 324 andpoppet end 266 can be applied from one side of reservoir poppet 318.Thus, the spring force applied by actuating bar 310 is not completelyalong a longitudinal axis of reservoir poppet 318. The spring force isapplied in both the axial and transverse/sideways directions to poppetend 266. The sideways force has the unintended consequence of tippingreservoir poppet 318 sideways into valve block 317. In response, valveblock 317 tends to deform and potentially causes reservoir poppet 318 tobe misaligned. This misalignment results in reservoir poppet 318 beingrestrained from moving axially into valve block 317 to reach anactivated/open position. As shown in FIGS. 26A-28, a stiff poppetsupport 320 is provided to prevent the misalignment of reservoir poppet318.

[0137] As shown in FIG. 27, poppet support 320 is an elongate, generallyL-shaped member comprising a shelf 342 at one end of poppet support 320.Apertures 344 are provided in a portion of support 320 to attach thesupport 320 to valve block 317. See FIGS. 26 and 27. The poppet support320 wraps around a portion of the valve block 317 and rests against aportion of poppet end 266. The shelf 342 provides a smooth surface for asegment of reservoir poppet 318 to slide axially along during reservoirpoppet 318 travel between open and closed positions. During actuation,curved portion 325 of actuating bar 310 applies a spring force,comprising both axial and side forces, to move reservoir poppet 318 toan open position. Poppet support 342 prevents sideways movement of thereservoir poppet 318 as it is forced into the interior of the valve body317. Poppet support 320 ensures the proper alignment of reservoir poppet318 to easily move axially into valve body 317 to the open position.

[0138] Various embodiments have been shown and described to preventspontaneous inflation. It is to be understood that though theseembodiments have been shown and described in isolation, various featuresof each embodiment can be combined with the others to produce a varietyof embodiments.

[0139] While the present invention has been described with respect to apump and valve assembly for a penile implant, the use of generatedoverpressure to seal a fluid aperture has many other applications withinthe scope and spirit of the present invention. For example, artificialsphincters utilize fluid pressure to maintain a body cavity or naturalpassageway in a closed or sealed state. When actuated, fluid pressure isreleased from the sphincter, causing the bodies' passageway to open. Assuch, the fluid pressure generated could be used to assist theartificial sphincter in either state. Likewise, many other uses for anoverpressure seal exist, both specifically within the field of medicaldevices and within the field of fluid/gas handling devices in general.

[0140] Those skilled in the art will further appreciate that the presentinvention may be embodied in other specific forms without departing fromthe spirit or central attributes thereof. In that the foregoingdescription of the present invention discloses only exemplaryembodiments thereof, it is to be understood that other variations arecontemplated as being within the scope of the present invention.Accordingly, the present invention is not limited in the particularembodiments which have been described in detail therein. Rather,reference should be made to the appended claims as indicative of thescope and content of the present invention.

What is claimed is:
 1. A pump assembly for an implantable prosthesis,comprising: a housing having a fluid passageway, the fluid passagewayhaving an inlet and an outlet; a first flow valve located within thefluid passageway between the inlet and the outlet, and a supplementalbiasing mechanism responsive to inadvertent pressure increases from theinlet to supplement a sealing capability of the first flow valve.
 2. Thepump assembly of claim 1, wherein the supplemental biasing mechanismfurther includes: a flexible flap in contact with the first flow valvewhen the first flow valve is in a closed position so that as fluidpressure from the inlet increases, the flexible flap is caused to sealmore firmly against the first flow valve.
 3. The pump assembly of claim2 further comprising: a tapered passageway for receiving the first flowvalve, wherein the flexible flap is part of the tapered passageway. 4.The pump assembly of claim 1, wherein the supplemental biasing mechanismfurther includes: a relief area in contact with the first flow valvewhen the first flow valve is in a closed position, so that as pressurefrom the inlet increases the relief area expands and further sealsagainst the first flow valve.
 5. The pump assembly of claim 1 whereinthe supplemental biasing mechanism further includes: a reservoir chamberdisposed within the housing between the inlet and the first flow valve,wherein the reservoir chamber includes an outer wall; and a portion ofthe first flow valve which extends into the reservoir chamber and iscoupled to the outer wall, so that as fluid pressure within thereservoir chamber increases the outer wall is caused to flex, pullingthe flow valve towards a closed position.
 6. The pump assembly of claim5 further including: a spring coupling the flow valve to the outer wall.7. The pump assembly of claim 6 wherein the spring is biased to maintainthe flow valve in close proximity to the outer wall so that as the fluidpressure increases in the reservoir chamber, the spring will aid in theintentional unseating of the flow valve after a pump bulb compression.8. The pump assembly of claim 5 further comprising: a second flow valve,disposed between the first flow valve and the outlet.
 9. The pumpassembly of claim 5 wherein a tip of the first flow valve is directlyconnected the outer wall.
 10. The pump assembly of claim 9 wherein thetip includes a T-shaped portion that is recessed behind at least oneslot in the outer wall.
 11. The pump assembly of claim 1, wherein thesupplemental biasing mechanism includes: a spring biasing the first flowvalve into a sealed position, wherein the biasing force of the spring isselected to be strong enough to oppose pressures generated in anoverpressurization situation within a reservoir and keep the second flowvalve in the sealed position.
 12. The pump assembly of claim 11, furtherincluding: a face coupled to the first valve wherein the face has alarge diameter compared to a diameter of the remainder of the first flowvalve so that suction forces generated after a compression of a pumpbulb act on a sufficient surface area of the face to overcome thebiasing force of the spring.
 13. The pump assembly of claim 12 furtherincluding: a first lip seal located within the housing for selectivelyengaging an inner diameter portion of the face in a substantially fluidtight manner; and a second lip seal located within the housing forselectively engaging an outer diameter portion of the face in asubstantially fluid tight manner.
 14. The pump assembly of claim 1,wherein the supplemental biasing mechanism further includes: a frontface on the first flow valve for selectively sealing and unsealing anopening to the inlet; a rear section protruding from the first flowvalve away from the opening, including an internal fluid passageway anda throughbore providing access into the internal fluid passageway and anoutlet providing an egress from the internal fluid passageway; a valvesleeve slidably engaging the rear section to selectively seal and unsealthe throughbore so that as higher pressure levels are generated withinthe inlet, the front face of the first flow valve is caused to unsealthe opening and the valve sleeve is caused to seal the throughbore,wherein the valve sleeve contacts a portion of the housing and preventsfluid flow to the outlet.
 15. The pump assembly of claim 1, wherein thesupplemental biasing mechanism further includes: a conical lip sealselectively engageable with a stem portion of the first flow valve,wherein the stem portion includes a cylindrical portion and a groove sothat when the groove is positioned adjacent the conical lip seal fluidflow is permitted and when the cylindrical portion is positionedadjacent the conical lip seal fluid flow is prevented in direction fromthe inlet to the outlet.
 16. The pump assembly of claim 15, comprising;a face forming a portion of the first flow valve, wherein the face isselectively engageable with and biased towards a valve seat; and anannulus spaced from the valve seat and allowing the face to be forciblymoved therethrough so that the face is retained on a first side or asecond side of the annulus.
 17. The pump assembly of claim 16, furthercomprising: a spacer separating a rear portion of the face from theannulus when said face is positioned between the annulus and the valveseat so that fluid flow is permitted around the rear portion and throughthe annulus.
 18. The pump assembly of claim 17 wherein the spacer is aplurality of bumps located on the annulus.
 19. A penile prosthesiscomprising: a housing; a fluid inlet to the housing, coupleable to areservoir; a fluid outlet from the housing, coupleable to an inflatablecylinder; a fluid passageway coupling the inlet to the outlet; a firstcheck valve disposed within the fluid passageway and biased towards aclosed position; a second check valve disposed within the fluidpassageway and biased towards a closed position; a pump bulb in fluidcommunication with the fluid passageway between the first and secondcheck valves; and a reservoir chamber coupling the inlet to the fluidpassageway, wherein a portion of the first check valve extends into thereservoir chamber and is coupled to an outer wall of the reservoirchamber so that as fluid pressure within the reservoir chamberincreases, an expansion of the reservoir chamber occurs which urges thefirst check valve towards a closed position.
 20. The prosthesis of claim19 wherein a negative pressure generated by an expansion of the pumpbulb is sufficient to open the first check valve.
 21. The prosthesis ofclaim 19 further including a spring coupling the flow valve to the outerwall.
 22. The prosthesis of claim 19 wherein the spring is biased tomaintain the first check valve in close proximity to the outer wall sothat as the fluid pressure increases in the reservoir chamber, thebiasing of the spring will aid in the intentional unseating of the flowvalve after a pump bulb compression.
 23. A method of preventinginadvertent inflation of an implantable prosthetic comprising the stepsof: biasing a valve assembly such that an outlet is substantiallyclosed; and using inadvertent pressure increases from the inlet tosupplement the biasing of the valve assembly.
 24. The method of claim23, wherein the step of using inadvertent pressure includes: preventingfluid flow through the outlet by selectively varying fluid pressurewithin a bypass passageway having a first end which is in fluidcommunication with an inlet and a second end which is in fluidcommunication with a chamber.
 25. The method of claim 24, furthercomprising the steps of: displacing a flexible abutting wall disposedbetween the chamber and the valve assembly so that the abutting wall iscaused to contact the valve assembly and urge the valve assembly into aclosed position when the fluid pressure within the chamber exceeds apredetermined amount.
 26. The method of claim 24, further comprising thesteps of: sliding a valve sleeve along a rear portion of the valveassembly to occlude a passageway leading through a portion of the valveassembly and to sealingly engage a portion of housing.
 27. A method ofpreventing inadvertent inflation of an implantable prosthetic comprisingthe steps of: biasing a valve assembly such that an outlet issubstantially closed, wherein a biasing mechanism is sufficiently strongto oppose increased pressure levels generated during anoverpressurization situation; providing a sufficient surface area on thevalve assembly so that vacuum forces generated after a compression of apump bulb are sufficient to open the valve assembly.
 28. A pressure lockout arrangement for an inflatable prosthesis comprising: a housinghaving an inlet and an outlet; a valve disposed between the inlet andthe outlet, the valve being biased toward substantially sealing theoutlet; and a supplemental biasing mechanism responsive to inadvertentpressure increases from the inlet to increase the biasing of the valvetoward at least substantially sealing the outlet.
 29. The pressure lockout of claim 28 wherein the supplemental biasing mechanism furthercomprises: a front face on the valve for selectively sealing andunsealing an opening to the inlet; a rear section protruding from thevalve and away from the opening, including an internal fluid passagewayand a throughbore providing access into the internal fluid passagewayand an outlet providing an egress from the internal fluid passageway; avalve sleeve slidably engaging the rear section to selectively seal andunseal the throughbore so that as higher pressure levels are generatedwithin the inlet, the front face of the valve is caused to unseal theopening and the valve sleeve is caused to seal the throughbore, whereinthe valve sleeve contacts a portion of the housing and prevents fluidflow to the outlet.
 30. The pressure lock out of claim 28 wherein thesupplemental biasing mechanism further comprises: a front face on thevalve for selectively sealing and unsealing an opening to the inlet; arear section protruding from the valve and away from the opening,including an external fluid passageway having an outlet end; a valveslidably engaging the rear section to selectively seal and unseal theoutlet end so that as higher pressure levels are generated within theinlet, the front face of the valve is caused to unseal the opening andthe valve sleeve is caused to seal the outlet end, wherein the valvesleeve contacts a portion of the housing and prevents fluid flow to theoutlet end.
 31. The pressure lock out of claim 28 wherein thesupplemental biasing mechanism further comprises: a reservoir chamberdisposed within the housing between the inlet and the valve, wherein thereservoir chamber includes an outer wall; and a portion of the flowvalve which extends into the reservoir chamber and is coupled to theouter wall, so that as fluid pressure within the reservoir chamberincreases the outer wall is caused to flex, pulling the flow valvetowards a closed position.
 32. The pressure lock out of claim 28 furtherincluding: a spring coupling the flow valve to the outer wall.
 33. Thepressure lock out of claim 28, wherein the supplemental biasingmechanism further includes: a conical lip seal selectively engageablewith a stem portion of the valve, wherein the stem portion includes acylindrical portion and a groove so that when the groove is positionedadjacent the conical lip seal fluid flow is permitted and when thecylindrical portion is positioned adjacent the conical lip seal fluidflow is prevented in a direction from the inlet to the outlet.
 34. Thepressure lock out of claim 33, comprising; a face forming a portion ofthe valve, wherein the face is selectively engageable with and biasedtowards a valve seat; and an annulus spaced from the valve seat andallowing the face to be forcibly moved therethrough so that the face isretained on a first side or a second side of the annulus.
 35. Thepressure lock out of claim 34, further comprising: a spacer separating arear portion of the face from the annulus when said face is positionedbetween the annulus and the valve seat so that fluid flow is permittedaround the rear portion and through the annulus.
 36. The pressure lockout of claim 35 wherein the spacer is a plurality of bumps located onthe annulus.
 37. A penile prosthesis comprising: a housing; a fluidinlet to the housing, coupleable to a reservoir; a fluid outlet from thehousing, coupleable to an inflatable cylinder; a reservoir chamberdisposed within the housing and fluidly coupled to the inlet; a fluidpassageway fluidly coupled to the reservoir chamber; a first check valvedisposed within the fluid passageway and biased towards a closedposition; a second check valve disposed within the fluid passageway andbiased towards a closed position; a pump bulb in fluid communicationwith the fluid passageway between the first and second check valves; aspring biasing the first check valve into a sealed position, wherein thebiasing force of the spring is selected to be strong enough to opposepressures generated in an overpressurization situation and keep thesecond check valve in the sealed position; and a face coupled to thefirst check valve wherein the face has a large diameter compared to adiameter of the remainder of the flow valve so that suction forcesgenerated after a compression of a pump bulb act on a sufficient surfacearea of the face to overcome the biasing force of the spring.
 38. Thepump assembly of claim 37 further including: a first lip seal locatedwithin the housing for selectively engaging an inner diameter portion ofthe face in a substantially fluid tight manner; and a second lip seallocated within the housing for selectively engaging an outer diameterportion of the face in a substantially fluid tight manner.
 39. A penileprosthesis comprising: a housing; a fluid inlet to the housing,coupleable to a reservoir; a fluid outlet from the housing, coupleableto an inflatable cylinder; a reservoir chamber disposed within thehousing and fluidly coupled to the inlet; a fluid passageway fluidlycoupled to the reservoir chamber; a first check valve disposed withinthe fluid passageway and biased towards a closed position; a secondcheck valve disposed within the fluid passageway and biased towards aclosed position; a pump bulb in fluid communication with the fluidpassageway between the first and second check valves; a front face onthe first check valve for selectively sealing and unsealing an openingto the fluid inlet; a rear section protruding from the first check valveaway from the opening, including an internal fluid passageway and athroughbore providing access into the internal fluid passageway and anoutlet providing an egress from the internal fluid passageway; and avalve sleeve slidably engaging the rear section to selectively seal andunseal the throughbore so that as higher pressure levels are generatedwithin the inlet, front face of the first check valve is caused tounseal the opening and the valve sleeve is caused to seal thethroughbore, wherein the valve sleeve contacts a portion of the housingand prevents fluid flow to the outlet.
 40. A penile prosthesiscomprising: a housing; a fluid inlet to the housing, coupleable to areservoir; a fluid outlet from the housing, coupleable to an inflatablecylinder; a reservoir chamber disposed within the housing and fluidlycoupled to the inlet; a fluid passageway fluidly coupled to thereservoir chamber; a second check valve disposed within the fluidpassageway and biased towards a closed position; a first check valvedisposed within the fluid passageway and biased towards a closedposition, the first check valve having a front face for selectivelysealing and unsealing an opening to the fluid inlet and a rear stemsection protruding from the first check valve away from the opening,including a cylindrical portion and a groove; a pump bulb in fluidcommunication with the fluid passageway between the first and secondcheck valves; a conical lip seal integral with the housing andpositioned so that the rear stem section is moveable therein so thatwhen a cylindrical portion of the stem section is aligned with theconical lip seal, fluid flow in a direction from the inlet to the outletis prevented and increased pressure levels within the inlet serves tofurther seal the conical lip seal against the cylindrical portion of thestem section, and when the groove is aligned with the conical lip seal,fluid flow is permitted; and an annulus integral with the housingpositioned so as to cooperate with the front face, allowing the frontface to be forcibly move therethrough so that when the front face is ona first side of the annulus, the groove of the stem section is alignedwith the conical lip seal and when the front face is on a second side ofthe annulus the cylindrical portion of the stem is aligned with theconical lip seal.
 41. The penile prosthesis of claim 40, furthercomprising: a spacer separating a rear portion of the front face fromthe annulus when said front face is on said first side so that fluidflow is permitted around the rear portion and through the annulus. 42.The penile prosthesis of claim 41 wherein the spacer is a plurality ofbumps located on the annulus.
 43. A method of preventing a vacuum lockfrom occurring in a penile prosthesis having a valve movable through anannulus so that when on a first side of the annulus operation of theprosthesis is permitted and when on a second side, spontaneous inflationis prevented, comprising: positioning the valve on the first side of theannulus; and providing a fluid path around the valve through the annuluswhen a rear face of the valve is proximate the annulus.
 44. The methodof claim 43 including the step of: providing at least one spacer toprevent the rear face from sealing against he annulus.
 45. The method ofclaim 44 including the step of providing at least one spacer that isintegral with the annulus.
 46. A pump assembly for an implantableprosthesis, comprising: a housing having a fluid passageway, the fluidpassageway having an inlet and an outlet; a first flow valve locatedwithin the fluid passageway between the inlet and the outlet; asupplemental biasing mechanism responsive to inadvertent pressureincreases from the inlet to supplement the sealing capabilities of thefirst flow valve; and a pump bulb in fluid communication with the fluidpassageway.
 47. The pump assembly of claim 46, further comprising: a barpositioned within the housing and moveable between a first and a secondposition so that when the bar is moved from a first position to a secondposition the bar causes the first flow valve to move from a closed to anopen position to deflate the implantable prosthesis.
 48. The pumpassembly of claim 47 further comprising: a support member coupled to thehousing, wherein the support member prevents the first flow valve frommoving sideways relative to a major axis of the fluid passageway. 49.The pump assembly of claim 47, wherein the supplemental biasingmechanism further includes: a relief area in contact with the first flowvalve when the first flow valve is in a closed position, so that aspressure from the inlet increases the relief area further seals againstthe first flow valve.
 50. The pump assembly of claim 47 wherein thesupplemental biasing mechanism further includes: a reservoir chamberdisposed within the housing, wherein the reservoir chamber includes anouter wall; and a portion of the first flow valve which extends into thereservoir chamber and is coupled to the outer wall, so that as fluidpressure within the reservoir chamber increases the outer wall is causedto flex, pulling the flow valve towards a closed position.
 51. The pumpassembly of claim 50 further including: a spring coupling the flow valveto the outer wall.
 52. The pump assembly of claim 51 wherein the springis biased to maintain the flow valve in close proximity to the outerwall so that the spring will aid in the intentional unseating of theflow valve after a pump bulb compression.
 53. The pump assembly of claim51 further comprising: a second flow valve, disposed between the firstflow valve and the outlet.
 54. The pump assembly of claim 46 wherein thefirst flow valve is made of a metallic material, and a plastic member isattached to a portion of the first flow valve covering said metallicmaterial.
 55. The pump assembly of claim 48, wherein the supplementalbiasing mechanism further includes: a front face on the first flow valvefor selectively sealing and unsealing an opening to the inlet; a rearsection protruding from the first flow valve away from the opening,including an internal fluid passageway and a throughbore providingaccess into the internal fluid passageway and an outlet providing anegress from the internal fluid passageway; and a valve sleeve slidablyengaging the rear section to selectively seal and unseal the throughboreso that as higher pressure levels are generated within the inlet, thefront face of the first flow valve is caused to unseal the opening andthe valve sleeve is caused to seal the throughbore, wherein the valvesleeve contacts a portion of the housing and prevents fluid flow to theoutlet.
 56. The pump assembly of claim 47, wherein the supplementalbiasing mechanism further includes: a conical lip seal selectivelyengageable with a stem portion of the first flow valve, wherein the stemportion includes a cylindrical portion and a groove so that when thegroove is positioned adjacent the conical lip seal, fluid flow ispermitted, and when the cylindrical portion is positioned adjacent theconical lip seal, fluid flow is prevented in a direction from the inletto the outlet.
 57. The pump assembly of claim 56, comprising; a faceforming a portion of the first flow valve, wherein the face isselectively engageable with and biased towards a valve seat; and anannulus spaced from the valve seat and allowing the face to be forciblymoved therethrough so that the face is retained on a first side or asecond side of the annulus.
 58. The pump assembly of claim 57, furthercomprising: a spacer separating a rear portion of the face from theannulus when said face is positioned between the annulus and the valveseat so that fluid flow is permitted around the rear portion and throughthe annulus.
 59. The pump assembly of claim 58 wherein the spacer is aplurality of bumps located on the annulus.
 60. A penile prosthesiscomprising: a housing; a fluid inlet to the housing, coupleable to areservoir; a fluid outlet from the housing, coupleable to an inflatablecylinder; a fluid passageway coupling the inlet to the outlet; a firstcheck valve disposed within the fluid passageway and biased towards aclosed position; a second check valve disposed within the fluidpassageway and biased towards a closed position; a pump bulb in fluidcommunication with the fluid passageway between the first and secondcheck valves, wherein a negative pressure generated by an expansion ofthe pump bulb is sufficient to open the first check valve; and areservoir chamber coupling the inlet to the fluid passageway, wherein aportion of the first check valve extends into the reservoir chamber andis coupled to an outer wall of the reservoir chamber so that as fluidpressure within the reservoir chamber increases, an expansion of thereservoir chamber occurs which urges the first check valve towards aclosed position.
 61. The prosthesis of claim 60 further including: a barpositioned within the housing and moveable between a first and a secondposition so that when the bar is moved from the first position to thesecond position the bar causes the first check valve to move from aclosed position to an open position to deflate the implantableprosthesis, wherein the bar comprises a spring; a support member coupledto the housing and mechanically linked to the first check valve toprevent transverse movement of first check valve relative to the majoraxis of the fluid passageway when the first check valve is moving froman open to a closed position; and the first check valve is made of ametallic material with a plastic member disposed over a portion of thefirst check valve.
 62. The prosthesis of claim 60 further including: aspring coupling the flow valve to the outer wall; the bar furthercomprising at least one rib extending across a bend such that a springis created to afford the movement of the first check valve from a closedto an open position for deflation of the prosthesis.
 63. The prosthesisof claim 60 wherein the spring is biased to maintain the first checkvalve in close proximity to the outer wall, and the biasing of thespring affording the intentional unseating of the flow valve after apump bulb compression.
 64. A method of preventing inadvertent inflationof an implantable prosthetic comprising: biasing a valve assembly suchthat an outlet is substantially closed, wherein a biasing mechanism issufficiently strong to oppose increased pressure levels generated duringan overpressurization situation; providing a support mechanismmechanically linked to the valve assembly to prevent sideward movementof a valve when moving between an open and a closed position; andproviding a sufficient surface area on the valve assembly so that vacuumforces generated after a compression of a pump bulb are sufficient toopen the valve assembly.
 65. A pressure lock out arrangement for aninflatable prosthesis comprising: a housing having an inlet and anoutlet; a valve disposed between the inlet and the outlet, the valvebeing biased toward substantially sealing the outlet, the valve made ofmetallic material with a plastic member disposed over a portion of thevalve; and a supplemental biasing mechanism responsive to inadvertentpressure increases from the inlet to increase the biasing of the valvetoward substantially sealing the outlet.
 66. The pressure lock out ofclaim 65 wherein the supplemental biasing mechanism further comprises: afront face on the valve for selectively sealing and unsealing an openingto the inlet; a rear section protruding from the valve and away from theopening, including an internal fluid passageway and a throughboreproviding access into the internal fluid passageway and an outletproviding an egress from the internal fluid passageway; a valve sleeveslidably engaging the rear section to selectively seal and unseal thethroughbore so that as higher pressure levels are generated within theinlet, the front face of the valve is caused to unseal the opening andthe valve sleeve is caused to seal the throughbore, wherein the valvesleeve contacts a portion of the housing and prevents fluid flow to theoutlet.
 67. The pressure lock out of claim 65 wherein the supplementalbiasing mechanism further comprises: a front face on the valve forselectively sealing and unsealing an opening to the inlet; a rearsection protruding from the valve away from the opening, including anexternal fluid passageway having an outlet end; a valve slidablyengaging the rear section to selectively seal and unseal the outlet endso that as higher pressure levels are generated within the inlet, thefront face of the valve is caused to unseal the opening and the valvesleeve is caused to seal the outlet end, wherein the valve sleevecontacts a portion of the housing and prevents fluid flow to the outletend.
 68. The pressure lock out of claim 65 wherein the supplementalbiasing mechanism further comprises: a reservoir chamber disposed withinthe housing between the inlet and the valve, wherein the reservoirchamber includes an outer wall; and a portion of the flow valve whichextends into the reservoir chamber and is coupled to the outer wall, sothat as fluid pressure within the reservoir chamber increases the outerwall is caused to flex, pulling the flow valve towards a closedposition.
 69. The pressure lock out of claim 65, wherein thesupplemental biasing mechanism further includes: a conical lip sealselectively engageable with a stem portion of the valve, wherein thestem portion includes a cylindrical portion and a groove so that whenthe groove is positioned adjacent the conical lip seal fluid flow ispermitted and when the cylindrical portion is positioned adjacent theconical lip seal fluid flow is prevented in direction from the inlet tothe outlet.
 70. The pressure lock out of claim 69, comprising; a faceforming a portion of the valve, wherein the face is selectivelyengageable with and biased towards a valve seat; and an annulus spacedfrom the valve seat and allowing the face to be forcibly movedtherethrough so that the face is retained on a first side or a secondside of the annulus.
 71. The pressure lock out of claim 70, furthercomprising: a spacer separating a rear portion of the face from theannulus when said face is positioned between the annulus and the valveseat so that fluid flow is permitted around the rear portion and throughthe annulus.
 72. The pressure lock out of claim 71 wherein the spacer isa plurality of bumps located on the annulus.
 73. A penile prosthesiscomprising: a housing; a fluid inlet to the housing, coupleable to areservoir; a fluid outlet from the housing, coupleable to an inflatablecylinder; a reservoir chamber disposed within the housing and fluidlycoupled to the inlet; a fluid passageway fluidly coupled to thereservoir chamber; a first check valve disposed within the fluidpassageway and biased towards a closed position, the first check valvemade of a metallic material with a plastic member disposed over aportion of the first check valve; a second check valve disposed withinthe fluid passageway and biased towards a closed position; a pump bulbin fluid communication with the fluid passageway between the first andsecond check valves; a bar positioned within the housing and moveablebetween a first and a second position so that when the bar is moved fromthe first position to the second position the bar causes the first checkvalve to move from a closed position to an open position to deflate theimplantable prosthesis, wherein the bar comprises a spring; a supportmember coupled to the housing and mechanically linked to the first checkvalve to prevent transverse movement of first check valve relative tothe major axis of the fluid passageway when the first check valve ismoving from an open to a closed position, a spring biasing the firstcheck valve into a sealed position, wherein the biasing force of thespring is selected to be strong enough to oppose pressures generated inan overpressurization situation and keep the second check valve in thesealed position; and a face coupled to the first check valve wherein theface has a large diameter compared to a diameter of the remainder of theflow valve so that suction forces generated after a compression of apump bulb act on a sufficient surface area of the face to overcome thebiasing force of the spring.
 74. The prosthesis of claim 73 furtherincluding: a first lip seal located within the housing for selectivelyengaging an inner diameter portion of the face in a substantially fluidtight manner; and a second lip seal located within the housing forselectively engaging an outer diameter portion of the face in asubstantially fluid tight manner.